Negative Pressure Ventilation Imapcts Weaning Ventilator In Medical Intensive Care Units (ICUs)

Respiratory Failure Clinical Trial

Official title:

Phase 2 Study of Negative Pressure Ventilation That Imapcts Weaning Ventilator in Medical Intensive Care Units

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01155596
• Other study ID #: 98-3276B
• Status: Unknown status
• Phase: Phase 2
• First received: May 30, 2010
• Last updated: July 1, 2010
• Start date: March 2010
• Est. completion date: March 2011

Study information

• Verified date: June 2010
• Source: Chang Gung Memorial Hospital
• Contact: Horng-Chyuan Lin
• Email: lin53424[@]ms13.hinet.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Quasi-experimental research design. The subjects are limited in intensive care unit within north medical center hospital. All subjects depend on ventilator and receive weaning plans. Experimental group is weaning with the support of negative pressure ventilator .The investigators collect basic personal variables in the questionnaire, APACHE Ⅱ scale, Dyspnea scale and arterial blood gas analysis and ventilator weaning index. Compare experimental group and control group data. Data will be Statistical analyzed by: descriptive statistics (such as: mean, standard deviation, median, frequency, percentage) and inferential statistics (such as: Independent T-test, Pair T-test, Mann-Whitney U test), P-value <0.05 will consider to be statistically significant.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 120
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Acute respiratory failure patients in medical ICUs

Exclusion Criteria:

• Age<20 years old

• Malignancy

• Pregnancy

Related Conditions & MeSH terms

• Respiratory Failure
• Respiratory Insufficiency

Intervention

Behavioral:
• negative pressure ventilator use
Body ventilators that assist ventilation by applying intermittent subatmospheric pressure around the thorax, abdomen, or airway and periodically expand the chest wall and inflate the lungs. They are relatively simple to operate and do not require tracheostomy. Chest cuirass is used in this study.

Locations

Country	Name	City	State
Taiwan	Gung Memorial Hospital, Chang Gung University, College of Medicine.	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ventilator weaning rate		28 days
Secondary	ICU stay		28 days